K012597 is an FDA 510(k) clearance for the STERILMED REPROCESSED COMPRESSION SLEEVES. This device is classified as a Sleeve, Limb, Compressible (Class II - Special Controls, product code JOW).
Submitted by Sterilmed, Inc. (Maple Grove, US). The FDA issued a Cleared decision on February 11, 2002, 185 days after receiving the submission on August 10, 2001.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5800.
| 510(k) Number | K012597 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 10, 2001 |
| Decision Date | February 11, 2002 |
| Days to Decision | 185 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | JOW — Sleeve, Limb, Compressible |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5800 |